Related Manuals for AW Technologies TrachFlush
Summary of Contents for AW Technologies TrachFlush
- Page 1 Instructions for Use TF-SA-XX Software version 4.0.x.x AWT-1030 | 2022-10-12 English | AWT-1030 #4.0 TrachFlush Instructions for Use...
- Page 2 TrachFlush Instructions for Use October 2022 AWT-1030 English | AWT-1030 #4.0 TrachFlush Instructions for Use...
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Page 3: Table Of Contents
Information Signals ............................30 Mounting the TrachFlush device ........................ 32 Cleaning and maintenance ......................... 33 10.1. Cleaning of TrachFlush device and equipment ....................33 10.2. Disposal of Cuff Pressure and Airway Tube set ..................... 33 10.3. Maintenance of TrachFlush device ........................ 33 10.4. - Page 4 Technologies ApS, Denmark. While the information set forth herein is believed to be accurate, it is not a substitute for the exercise of professional judgment. Nothing in this document shall limit or restrict in any way AW Technologies ApS’s right to revise or otherwise change or modify the equipment (including its software) described herein, without notice.
- Page 5 • The use of this equipment is restricted to one patient at a time who is intubated with an endotracheal tube (ETT) or tracheostomy tube (TT). • If there is visible damage to any part of the TrachFlush device, do not use the device. Technical service is required.
- Page 6 • Install the TrachFlush device in a position where the primary power supply can easily be disconnected. • To electrically isolate the TrachFlush device from all poles of the primary power supply simultaneously, disconnect the power plug. • The device is not protected against the effects of defibrillator use.
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Page 7: Device Overview
6. Unit of measure 7. Adjustment buttons Control panel 8. Deflate button 9. Cuff hold information bar 10. Cuff hold button 11. Alarm bar (LED) 12. Flush Button Figure 1: Device overview English | AWT-1030 #4.0 TrachFlush Instructions for Use... -
Page 8: Trachflush Connections
Figure 2: TrachFlush Setup Overview NOTICE Only #1, #2, #3, and #4 above is a part of the TrachFlush device. The elbow connector (#5) and the endotracheal tube (#6) is not a part of the TrachFlush device but is shown here for connectivity overview. -
Page 9: Getting Started
TrachFlush can ONLY be used with ETT cuffs or TT cuffs made of these materials. Prior to use, confirm that the ETT or TT is between 5.0mm and 10.0mm in Inner Diameter (ID) as TrachFlush only supports ETTs and TTs in these sizes. -
Page 10: Turning On The Device
3.2. Turning ON the device Press and hold the Power ON / OFF button for three (3) seconds. Figure 4: Turning on TrachFlush When turning on, the device performs a self-test, during which the display turns on, LED-bar lights up and the alarm sounds, and the signal (booting) will appear on the screen. - Page 11 If TrachFlush detects that the tubes are not removed prior to calibration, the text will be highlighted in red as shown in Figure 7. Figure 7: TrachFlush detects tubes are not disconnected Once the device is calibrated, the main screen will appear (as shown in Figure 8) and Cuff Control functionality will be OFF until pressure is set, see section 3.5.
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Page 12: Connect The Cuff Pressure Tube And Airway Tube To The Device
TrachFlush by twisting it on as shown in Figure 9. Figure 9: Device connectivity, connecting Cuff Pressure Tube Step 2: Connect the Airway Tube (pink tube) connector to the airway inlet socket of the TrachFlush device by twisting it on as shown in Figure 10. -
Page 13: Connect The Cuff Pressure Tube And Airway Tube To The Patient
Step 2: Connect the Cuff Pressure Tube (transparent tube) connector (labelled “Cuff”) to the ETT or TT cuff connector by pushing it in as shown in Figure 12 Figure 12: Patient connectivity, connecting Cuff Pressure Tube English | AWT-1030 #4.0 TrachFlush Instructions for Use... -
Page 14: Adjust Cuff Pressure
It is recommended to keep the cuff pressure between 25cmH O and 30cmH O for adult ETTs/TTs. TrachFlush Cuff Controller can regulate cuff pressures between 5 and 50cmH To adjust the set (target) pressure: Step 1: Press the (increase) or (decrease) button to increase or decrease the cuff pressure. -
Page 15: Flush Control
Upon activation, the device checks the ventilator settings to ensure the function activates under proper conditions, see section 14.1 for information on appropriate ventilator settings. By default, the cuff will after the deflation automatically return to the set target pressure. English | AWT-1030 #4.0 TrachFlush Instructions for Use... -
Page 16: Perform Flush Control On Pressure Control Ventilation (Pcv)
Cuff pressure is between 15 cmH O and 35 cmH NOTICE TrachFlush will only perform the Flush Control maneuver if these ventilator and cuff pressure settings are met. Step 1: Press the Flush button to activate the Flush Control as shown in Figure 15 below Figure 15: Performing a Flush English | AWT-1030 #4.0... - Page 17 Figure 16: Flush in Progress NOTICE When Flush is activated, the TrachFlush device uses at least one (1) inspiratory cycle to check for correct ventilator settings as defined in Section 14.1. If the ventilator settings are found correct, on the next inspiratory cycle the Flush Control maneuver is performed.
- Page 18 Figure 18. Figure 18: Flush Complete After the “OK” button has been pressed to acknowledge the Flush is completed, TrachFlush returns to main screen as shown in Figure 19. Figure 19: Main screen Step 2(OPTIONAL): Evaluate the effect of the Flush Control maneuver and, if considered necessary, repeat Step 1.
- Page 19 Figure 20: Return to Pre-Flush Ventilator Settings English | AWT-1030 #4.0 TrachFlush Instructions for Use...
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Page 20: Perform Spont Flush Control On Pressure Support Ventilation (Psv)
Only adjust the ventilator settings if it is clinically safe for the patient and adjustments should only be temporarily when performing the Spont Flush Control maneuver. Remember to return settings. When a Spont Flush Control is activated, TrachFlush will perform the Flush during the next inspiratory cycle. Use ONLY on Pressure Support Ventilation (PSV). - Page 21 LED-bar will light cyan until the Spont Flush is completed, as shown in Figure 23. Figure 23: Spont Flushing Once the Spont Flush is completed, the signal (Flush Complete) and “OK” button will appear on the screen as shown in Figure 24. English | AWT-1030 #4.0 TrachFlush Instructions for Use...
- Page 22 Figure 24: Spont Flush Complete After the “OK” button has been pressed to acknowledge the Spont Flush is completed, TrachFlush returns to main screen as shown in Figure 25. Figure 25: Main screen Step 3: Repeat Step 1+2 (OPTIONAL): Evaluate the effect of the Spont Flush Control maneuver and, if considered necessary, repeat Step 1 and 2.
- Page 23 Figure 26: Return to Pre-Spont Flush Ventilator Settings English | AWT-1030 #4.0 TrachFlush Instructions for Use...
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Page 24: Deflate
By default, the cuff is kept deflated for un unlimited period. However, if the cuff is deflated for more than 60 seconds without being TrachFlush being turned off or the cuff reinflated, you are reminded that you deflated the cuff and that the cuff is still in the deflated state. -
Page 25: Perform Deflate
The target pressure displays “OFF”, and the device applies negative pressure until the actual pressure is at least 0 cmH After deflating the cuff, you can extubate the patient, disconnect the TrachFlush, and turn off the device. If the cuff is deflated for > 60 seconds without being reinflated or the device being turned off, you are reminded that you deflated the cuff and that the cuff is still in the deflated state. -
Page 26: Cuff Hold
You can change the increased pressure setting in 5 cmH O increments from a minimum of 5 O to a maximum of 25 cmH O and set the hold duration to either 5 or 10 minutes. English | AWT-1030 #4.0 TrachFlush Instructions for Use... -
Page 27: Perform Cuff Hold
Stop the cuff hold To stop the cuff hold, readjust the cuff pressure to the desired cuff pressure and accept, see section 3.5 on how to adjust pressure. The cuff hold will then turn off. English | AWT-1030 #4.0 TrachFlush Instructions for Use... -
Page 28: Turning Off The Device
Step 2: Disconnect the Airway Tube (pink tube) from the TrachFlush device and the Cuff Pressure Tube (transparent tube). Figure 30: Disconnect tubes from device Step 3: Turn off the TrachFlush device by pressing and holding the Power ON/OFF button for 3 seconds as shown in Figure 31 below. Figure 31: Turn off TrachFlush Step 4: Dispose the Cuff Pressure and Airway Tube as described in section 10.2. -
Page 29: Alarms And Troubleshooting
When an alarm is generated, the device emits audible beeps and the alarm lamp lights cyan, yellow or red, depending on the alarm priority. The TrachFlush device has three alarm priorities: high, medium, and low. See Table 1 and Table 2 for details. -
Page 30: Information Signals
Should multiple alarms occur at the same time, the alarm with the highest priority will be shown on top. 8.1. Information Signals Information signals are displayed to provide useful information to the operator of TrachFlush. In Table 3 you will find detailed information on possible causes and what to do for each information signal. - Page 31 Cuff pressure above set Light: No light. The cuff pressure is above Please wait until the set following a Flush TrachFlush has reduced the Audio: No audio. Control cuff pressure. Ventilator settings OK Light: No light. The ventilator settings Please wait, a Flush Control are correct.
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Page 32: Mounting The Trachflush Device
Mounting the TrachFlush device The TrachFlush has a bed-side bracket mounting option available. The back of the TrachFlush device is designed for the bed-side bracket to be attached directly using the included screws and hexagon key. 1. TrachFlush Bed-side bracket 2. -
Page 33: Cleaning And Maintenance
Be particularly careful with infectious patients and follow your hospital infection protocol procedures. Clean the TrachFlush device and bed-side bracket with a soft cloth moistened in water or a mild soap solution. To disinfect the equipment, wipe with 70% isopropyl alcohol. -
Page 34: Intended Use And Operators
Intensive Care Unit (ICU) when activated by the user. TrachFlush is to be used during mechanical ventilation in the ICU of adults who are intubated with ETT or TT TrachFlush is intended to be used in healthcare institution ICUs TrachFlush can be used with any mechanical ventilator. -
Page 35: Emc Declarations Iec 60601-1-2:2014
Portable RF equipment and communications devices (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the TrachFlush device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this... -
Page 36: Electromagnetic Environment - Guidance
Guidance and manufacturer’s declaration – electromagnetic emissions TrachFlush is intended for use in the electromagnetic environment specified below. The customer or the user of the TrachFlush device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –... - Page 37 Guidance and manufacturer’s declaration – electromagnetic immunity TrachFlush is intended for use in the electromagnetic environment specified below. The customer or the user of the TrachFlush device should assure that it is used in such an environment. Electromagnetic...
- Page 38 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which TrachFlush is used exceeds the applicable RF compliance level, TrachFlush should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating TrachFlush.
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Page 39: Specifications
55 dB(A) ± 6 dB(A) Environmental conditions Relative humidity 30% to 75% Operating temperature 5°C to 40°C Operating atmospheric pressure range 70,0 kPa to 106,0 kPa Operational noise level < 40 dB(A) English | AWT-1030 #4.0 TrachFlush Instructions for Use... -
Page 40: Symbols On Labels
Type BF Applied Part (IEC 60601-1) (protection against electrical shock) DC Current/Voltage Manufacturer information Serial number Batch code AW Technologies Reference or Part Number Date of manufacture Do not reuse Do not use if packaging is damaged Use-by-date Not made with natural rubber latex... -
Page 41: Parts And Accessories
15. Parts and accessories Name AW Technologies Part number Cuff Pressure and Airway Tube set TF-SA-XX Bed-side bracket TF-SA-B Power Supply 2 meters incl. adaptors TF-SA-PSU English | AWT-1030 #4.0 TrachFlush Instructions for Use... -
Page 42: Warranty
Limited Warranty of the device. To obtain service under this Limited Warranty, claimant must promptly notify the country’s sales partner of AW Technologies regarding the nature of the problem, serial number, and the date of purchase of the product. -
Page 43: Miscellaneous
Except as stated above, AW Technologies shall not be liable for any damages, claims or liabilities including, but not limited to, personal bodily injury, or incidental, consequential, or special damages. Nor will AW Technologies be liable for any damages, claims or liabilities including, but not limited to, personal bodily injury, incidental, consequential, or special damages resulting from misuse of the device or failure to comply with any of the provision made in this manual.
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